Medical Device and Importation Requirements for Tradeshows in EU
We have a legally marketed device in the USA (class II), but would like to exhibit this same device in the EU at an upcoming tradeshow. It does not currently bear CE marking, but we plan to pursue this shortly. This would be a Class I device in the EU. What are the restrictions for doing so? The marketing department just asked me if they can send a shipment over in preparation. I'm sure that it would get held up at importation. Also, are there any preselling restrictions? Thanks in advance.